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J Clin Oncol. 2013 Sep 10;31(26):3212-8. doi: 10.1200/JCO.2012.47.2464. Epub 2013 Aug 12.

Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma.

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Tracy T. Batchelor, Rakesh K. Jain, and Gregory Sorensen, Massachusetts General Hospital, Boston, MA; Paul Mulholland, University College London, London; Rao Gattamaneni, the Christie Foundation Trust Hospital, Manchester, United Kingdom; Bart Neyns, Universitair Ziekenhuis Brussel, Brussels, Belgium; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; Mario Campone, Centre Rene Gauducheau, Saint-Herblain, France; Antje Wick, University of Heidelberg, Heidelberg, Germany; Warren Mason, Princess Margaret Hospital, Toronto, Ontario, Canada; Tom Mikkelsen, Henry Ford Hospital, Detroit, MI; Surasak Phuphanich, Cedars-Sinai Medical Center, Los Angeles, CA; Lynn S. Ashby, Barrow Neurological Institute, Phoenix, AZ; John DeGroot, MD Anderson Cancer Center, Houston, TX; Lawrence Cher, Austin Health Cancer Services; Mark Rosenthal, Royal Melbourne Hospital, Melbourne, Australia; Franz Payer, Medical University, Graz, Austria; Juliane M. J├╝rgensmeier, John Xu, and Qi Liu, AstraZeneca, Wilmington, DE; and Martin van den Bent, Erasmus University Medical Center-Daniel den Hoed Cancer Center, Rotterdam, the Netherlands.



A randomized, phase III, placebo-controlled, partially blinded clinical trial (REGAL [Recent in in Glioblastoma Alone and With Lomustine]) was conducted to determine the efficacy of cediranib, an oral pan-vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor, either as monotherapy or in combination with lomustine versus lomustine in patients with recurrent glioblastoma.


Patients (N = 325) with recurrent glioblastoma who previously received radiation and temozolomide were randomly assigned 2:2:1 to receive (1) cediranib (30 mg) monotherapy; (2) cediranib (20 mg) plus lomustine (110 mg/m(2)); (3) lomustine (110 mg/m(2)) plus a placebo. The primary end point was progression-free survival based on blinded, independent radiographic assessment of postcontrast T1-weighted and noncontrast T2-weighted magnetic resonance imaging (MRI) brain scans.


The primary end point of progression-free survival (PFS) was not significantly different for either cediranib alone (hazard ratio [HR] = 1.05; 95% CI, 0.74 to 1.50; two-sided P = .90) or cediranib in combination with lomustine (HR = 0.76; 95% CI, 0.53 to 1.08; two-sided P = .16) versus lomustine based on independent or local review of postcontrast T1-weighted MRI.


This study did not meet its primary end point of PFS prolongation with cediranib either as monotherapy or in combination with lomustine versus lomustine in patients with recurrent glioblastoma, although cediranib showed evidence of clinical activity on some secondary end points including time to deterioration in neurologic status and corticosteroid-sparing effects.


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